{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Carlsbad",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66842",
      "recalling_firm": "Qualigen Inc",
      "address_1": "2042 Corte del Nogal",
      "address_2": "N/A",
      "postal_code": "92011-1438",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.",
      "recall_number": "Z-0548-2014",
      "product_description": "FastPack Testosterone Immunoassay   Chemilunescence assay for the determination of Testosterone    The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.",
      "product_quantity": "18",
      "reason_for_recall": "Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.",
      "recall_initiation_date": "20131108",
      "center_classification_date": "20131219",
      "termination_date": "20140918",
      "report_date": "20131225",
      "code_info": "Testosterone. Catalog Number 25000041. Lot Number 1310019-3P  Exp Date: 9/22/2014"
    }
  ]
}